Avastin

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Celldex has added another round of positive data demonstrating that its brain cancer vaccine rindopepimut--more formally called Rintega and less formally "rindo"--provided a clear though relatively modest average survival benefit for recurrent glioblastoma patients in a Phase II study. And with the initial data set from Phase III looming later in the year, the biotech is carefully moving forward with its ongoing dialogue with regulators to gauge just how receptive they may be to speeding up an approval.

Roche's Avastin has been on the market for more than a decade and boasts a long list of valuable approvals. But Roche is not sitting back the status quo, and continues to submit the drug for new uses. Now, the company racked up yet another OK for Avastin, scoring European approval for the drug in combination with chemotherapy to treat women with advanced cervical cancer months after the company got a similar decision from stateside regulators.

Did Novartis and Roche campaign against study data supporting cheap Avastin eye injections as a substitute for their own purpose-made vision drug Lucentis? The BMJ says they did, aiming to "undermine and divert attention" from trials pitting Lucentis against the much cheaper treatment.

Roche's Avastin is now two-for-two on converting recent FDA priority review designations into label expansions. Just three months after the cancer giant nabbed the agency's blessing for use in cervical cancer, regulators have approved the drug in combination with chemotherapy as a treatment for platinum-resistant, recurrent ovarian cancer.

Genentech CEO Ian Clark is again being publicly chastised for his company's decision to move three of its best-selling cancer drugs to specialty distributors. Groups representing more than 5,000 hospitals say, besides higher costs, the move is as likely to encourage counterfeiting as to deter it.

Regeneron and Bayer's Eylea has been racking up sales that have consistently topped analyst expectations since its U.S. rollout in late 2011. Now, new data may help it potentially top them in a market Novartis and Roche got to first.

THE LIBRARY: WEBINAR

Pharma companies can employ several strategies for obtaining expedited approvals-including, in some cases, acquiring them from other companies. This webinar will feature regulatory experts from the pharma industry who can provide tips on navigating these programs. Register Today!